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Physical & Chemical Examination, Specialist / 理化学試験担当者

Hikari, Yamaguchi
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0107157 Date posted 09/26/2023 Location Hikari, Yamaguchi

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Job Description



1. 医薬品GMP・関連法規制・ガイドラインおよびSOPを遵守して試験業務を計画・実行する

2. 生産計画と出荷計画に基いて試験計画を作成し、実行する

3. OOS/OOTおよび逸脱を適正に報告・調査する

4. 試験業務に関連する専門知識を共有してチームメンバーの能力向上を推進する

5. Speak upを推進して試験業務に関連する改善を提案し、実行する。

1-1. 医薬品GMPを遵守する重要性とSOPに記載された手順の意味を理解して業務試験を実行する

1-2. 査察や監査の際にSMEとして試験業務の内容を説明する

1-3. 変更提案を起票する(全ての試験担当者の業務ではなく、上長と協議のうえ変更提案起票業務の有無を決定する)

2-1. 使用可能な機器・予算・人員の範囲で試験業務を計画する

2-2. 試験計画に従って試験を実行する*1

3-1. OOS/OOT/逸脱等の問題を速やかに上司に報告する

3-2. OOS/OOT/逸脱等に対する根本原因の調査を行い、CAPA計画を含む調査報告書を作成する

4-1. 担当する試験方法および分析装置の原理を理解する

4-2. 試験方法や分析装置に関する教育を提供する*2

5-1. 質問や提案を推奨する「Speak Up」を実践する

5-2. 試験業務やラボの環境に関する改善提案を行う改善を提案し、実行する

5-3. コンプライアンス違反を報告する


<学歴> 大卒以上


  • 医薬品の製造あるいは品質管理に関する職務経験(3年以上)
  • HPLC/GCの取り扱い経験(1年以上)
  • 正確にデータ入力や資料作成を行う能力(Word/Excel等のPCスキル)
  • 個人およびチーム環境でも業務を遂行できる能力






















賞与: 原則年2回







Hikari, Japan

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Full time
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